REFERENCIAS BIBLIOGRÁFICAS / BIBLIOGRAPHICAL REFERENCES

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1.) Five-year follow-up of patients with benign prostatic hyperplasia treated with  finasteride. 

2.) Therapeutic effects of finasteride in benign prostatic hyperplasia: a randomized  double-blind controlled trial. 

3.) The effect of finasteride on prostate volume, urinary flow rate and symptom score in  men with benign prostatic hyperplasia. 

4.) [5-alpha-reductase inhibitors]. 

5.) Benign prostatic hyperplasia. 

6.) The potential for hormonal prevention trials. 

7.) 5 alpha-reductase inhibition by finasteride (Proscar) in epithelium and stroma of human  benign prostatic hyperplasia. 

8.) Pharmacological treatment of benign prostatic hyperplasia with finasteride: a clinical  review. 

9.) Medical therapy for benign prostatic hyperplasia: A review of the literature. 

10.) Pretreatment with finasteride decreases perioperative bleeding associated with  transurethral resection of the prostate. 

11.) Urinary retention in patients with BPH treated with finasteride or placebo over 4  years. Characterization of patients and ultimate outcomes.The PLESS Study Group. 

12.) Dihydrotestosterone and the concept of 5alpha-reductase inhibition in human benign  prostatic hyperplasia. 

13.) Chronic treatment with finasteride daily does not affect spermatogenesis or semen  production in young men. 

14.) Management of androgenetic alopecia. 

15.) Finasteride in the treatment of men with frontal male pattern hair loss. 

16.) Androgenetic alopecia in men: the scale of the problem and prospects for treatment. 

17.) [Androgenetic alopecia, hirsutism and hypertrichosis]. 

18.) Medical treatments for balding in men. 

19.) Understanding and managing common baldness. 

20.) Finasteride: a review of its use in male pattern hair loss. 

21.) Finasteride in the treatment of men with androgenetic alopecia. Finasteride Male  Pattern Hair Loss Study Group. 

22.) Genetic analysis of male pattern baldness and the 5alpha-reductase genes. 

23.) Effect of finasteride on human testicular steroidogenesis. 

24.) [Finasteride: a new drug for the treatment of male hirsutism and  androgenetic  alopecia]? 

25.) The 5 alpha-reductase system and its inhibitors. Recent development and its  perspective in treating androgen-dependent skin disorders. 

26.) Finasteride: a clinical review. 

27.) The effect of finasteride, a 5 alpha-reductase inhibitor, on scalp skin testosterone and  dihydrotestosterone concentrations in patients with male pattern baldness. 

28.) Finasteride: the first 5 alpha-reductase inhibitor. 

29.) Cytologic atypia in a 53-year-old man with finasteride-induced gynecomastia. 

30.) Reversible painful gynaecomastia induced by low dose finasteride (1 mg/day). 

31.) Measuring reversal of hair miniaturization in androgenetic alopecia by follicular counts 

in horizontal sections of serial scalp biopsies: results of finasteride 1 mg treatment of men  and postmenopausal women. 

32.) Improvement in androgenetic alopecia in 53-76-year-old men using oral finasteride. 

33.) New topical antiandrogenic formulations can stimulate hair growth in human bald  scalp grafted onto mice. 

34.) Current management of androgenetic alopecia in men. 

35.) Immunohistochemical localization of types 1 and 2 5alpha-reductase in human scalp. 

36.) The psychosocial consequences of androgenetic alopecia: a review of the research  literature. 

37.) Clinical dose ranging studies with finasteride, a type 2 5alpha-reductase inhibitor, in  men with male pattern hair loss. 

38.) The effects of finasteride on scalp skin and serum androgen levels in men with  androgenetic alopecia. 

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1.) Five-year follow-up of patients with benign prostatic hyperplasia treated with 

finasteride. 

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Eur Urol 1995;27(4):267-73 

Geller J 

Mercy Hospital and Medical Center, San Diego, CA 92103-2180, USA. 

In 18 of 55 original patients who completed 5 years of treatment with finasteride, significant reductions in prostate size were noted at 1 year and sustained thereafter. Symptom scores in these same patients were significantly improved or stable over the 5 years while maximal urinary flow rates were unchanged. Data from 15 of 18 other patients who dropped out of the study before 5 years showed changes in prostate size, symptom score and flow rates that were similar to those noted in patients treated for 5 years. No side effects were noted in this study except for sexual dysfunction, which occurred in less than 5% of the patients. With few exceptions, finasteride appears to arrest the process of BPH over a 5 year period as indicated by sustained reductions in prostate size accompanied by either symptomatic improvement or stability in all other patients. 

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2.) Therapeutic effects of finasteride in benign prostatic hyperplasia: a randomized 

double-blind controlled trial. 

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 J Formos Med Assoc 1995 Jan-Feb;94(1-2):37-41 

Yu HJ, Chiu TY, Lai MK 

Department of Urology, National Taiwan University Hospital, Taipei, R.O.C. 

The clinical effects of finasteride, a 5 alpha-reductase inhibitor, in patients with benign  prostatic hyperplasia (BPH) were evaluated in a double-blind, placebo-controlled study.  Forty-six patients with symptomatic BPH were randomly assigned to 2 groups, the  finasteride group and the placebo group. The finasteride group received 5 mg of  finasteride daily for 6 months. Prostate volume, urinary flow, urinary symptoms, serum  prostate-specific antigen (PSA) and adverse events were determined before and after  treatment. After 6 months of treatment the patients treated with 5 mg of finasteride per  day had a 30% decrease in their total urinary symptom score, a 14% decrease in prostate  volume and a 0.9 ng/dL decrease of PSA. Their maximal urinary flow rate increased by  1.42 mL per second and the mean urinary flow rate increased by 0.64 mL per second.  The patients given placebo showed no significant changes in their prostate volume, serum  PSA and maximal and mean urinary flow rate. However, the symptom scores in the  placebo group also decreased significantly. When compared with the placebo group,  those in the finasteride group had significantly lower prostate volume, serum PSA,  maximal urinary flow rate and urinary symptoms, but not mean urinary flow rate. The  frequency of adverse events was low in both the finasteride and placebo groups. These  results show that finasteride may be an effective and safe alternative for the treatment of  patients with BPH. 

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3.) The effect of finasteride on prostate volume, urinary flow rate and symptom score in 

men with benign prostatic hyperplasia. 

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Aust N Z J Surg 1995 Jan;65(1):35-9 

Nacey JN, Meffan PJ, Delahunt B 

Department of Surgery, Wellington School of Medicine, New Zealand. 

This study was designed to determine the efficacy of the 5 alpha-reductase inhibitor  finasteride (Proscar, MK-906) in men with reduced urinary flow rates and symptoms of  urinary outflow obstruction secondary to benign prostatic hyperplasia. Forty-five men  were randomized to one of three groups receiving either placebo, 1 mg/day or 5 mg/day  finasteride for the first 12 months of the study period. At the end of this period all men  received 5 mg/day finasteride for a further 2 years. Efficacy was determined by  measurement of prostate volume, maximum urinary flow rate, and symptom score using a  modified Boyarsky assessment. Prostate volume reduced by 20 and 27%, respectively,  for those on 1 and 5 mg after the first year. At 3 years the volume had reduced by 43%.  This reduction in prostate volume was associated with an improvement in maximum  urinary flow rate by 50% (1 mg), and 35% (5 mg) at 1 year, and 36% at 3 years. The  total, obstructive and non-obstructive symptom scores decreased (improved) for patients  on 1 and 5 mg finasteride, with the total score reducing by 33% from baseline at year 3.  The results demonstrate that finasteride causes a modest but significant clinical  improvement in men with urinary outflow obstruction secondary to benign prostatic 

hyperplasia. 

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4.) [5-alpha-reductase inhibitors]. 

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Acta Urol Belg 1994 Dec;62(4):23-31 

De Jaegher K, Kozyreff P, Claes H 

A reflection is made, on the one hand, on the lack of correlation between the intensity of  micturition problems and the volume of the prostate and, on the other hand, on the  different therapeutic approaches of irritative or obstructive voiding problems, and finally  on the insufficiently convincing activity of Finasteride. 

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5.) Benign prostatic hyperplasia. 

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Endocrinol Metab Clin North Am 1994 Dec;23(4):795-807 

Jonler M, Riehmann M, Brinkmann R, Bruskewitz RC 

Division of Urology, University of Wisconsin, Madison. 

Benign prostatic hyperplasia (BPH) is the most common cause of bladder outlet  obstruction and voiding symptoms in elderly men. The pathogenesis is not fully determined  but a combination of androgens and age are needed for development of BPH. Symptoms  of BPH are divided into obstructive and irritative symptoms but large interpersonal  variability is found and no specific BPH symptom exists. Treatment modalities include  surgery (TURP, TUIP, open prostatectomy, laser ablation, balloon dilatation,  hyperthermia and thermotherapy, and urethral stents) and medical therapy. TURP is the  gold standard treatment and TUIP is a safe and effective alternative to TURP in patients  with smaller prostates. Laser ablation, hyperthermia and thermotherapy, and urethral  stents are at the present time under investigation. Balloon dilatation is FDA-approved but  not often used because of low efficacy and poor long-term results. Medical treatment  includes alpha-blocker or finasteride treatment and is indicated in patients with moderate  to severe symptoms of BPH without a strong indication for surgery. 

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6.) The potential for hormonal prevention trials. 

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Cancer 1994 Nov 1;74(9 Suppl):2726-33 

Ford LG, Brawley OW, Perlman JA, Nayfield SG, Johnson KA, Kramer BS 

Detection and Community Oncology Program, National Cancer Institute, Bethesda, 

Maryland 20892. 

Breast and prostate cancer are significant causes of morbidity and mortality and are very  similar in etiology, epidemiology, and modalities of treatment. Investigational strategies in  the prevention of these malignancies also have strong parallels. The National Cancer  Institute is sponsoring several large scale clinical trials involving hormonal manipulation and  cancer prevention. In the Breast Cancer Prevention Trial, 16,000 women at high risk for  breast cancer are being randomized to receive the antiestrogen agent tamoxifen or  placebo for 5 years in an effort to determine if breast cancer development can be  inhibited. In a similar trial, the Prostate Cancer Prevention Trial, 18,000 men older than  55 years of age will be randomized to receive finasteride, a 5-alpha-reductase inhibitor,  or placebo to determine if inhibition of dihydrotestosterone synthesis in the prostate over a  prolonged period will lead to a decreased incidence of prostate cancer. Both clinical trials  offer the possibility of demonstrating that a hormonal intervention can decrease an  individual's risk of developing breast or prostate cancer. They also have the potential of  providing critical information about cancer risk, etiology, screening, and genetics, as well  as quantifying the risks and benefits of specific preventive interventions. 

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7.) 5 alpha-reductase inhibition by finasteride (Proscar) in epithelium and stroma of human 

benign prostatic hyperplasia. 

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Steroids 1994 Nov;59(11):616-20 

Weisser H, Tunn S, Debus M, Krieg M 

Institute of Clinical Chemistry and Laboratory Medicine, University Clinic Bergmannsheil, 

Bochum, Germany. 

Finasteride is a specific 5 alpha-reductase inhibitor that has been shown to reduce the size  of human benign prostatic hyperplasia (BPH) by inhibiting the intraprostatic conversion of  testosterone to 5 alpha-dihydrotestosterone. The aim of the present in vitro study was to  describe in more detail the inhibitory effect of finasteride on 5 alpha-reductase in  epithelium and stroma of human BPH. 5 alpha-Reductase activity in epithelium and  stroma was inhibited dose-dependently by finasteride. The mean IC50 (50% inhibitory  concentration) values, determined in the presence of various testosterone concentrations,  were generally 2- to 4-fold lower in epithelium than in stroma. With finasteride  concentrations greater than 5 nM, competitive inhibition of 5 alpha-reductase occurred  both in epithelium and stroma. The mean inhibition constant Ki[nM +/- SEM] was 7 +/- 3  and 31 +/- 3 in epithelium and stroma, respectively. In the presence of finasteride  concentrations < or = 5 nM, the epithelial 5 alpha-reductase seems to be inhibited in an  uncompetitive manner, whereas such low finasteride concentrations cause either no  inhibition (1-2 nM) or competitive inhibition (5 nM) in stroma. Our present study provides  evidence that the inhibitory effect of finasteride on 5 alpha-reductase is much stronger in  epithelium than in stroma. Therefore, it is conceivable that the global size-reduction of  BPH under finasteride treatment is primarily due to the regression of BPH epithelium. 

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8.) Pharmacological treatment of benign prostatic hyperplasia with finasteride: a clinical 

review. 

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Arch Esp Urol 1994 Nov;47(9):883-7; discussion 887-8 

Ekman P 

Department of Urology, Karolinska Hospital, Stockholm, Sweden. 

Finasteride acts by blocking the conversion of testosterone to 5  alpha-dihydrotestosterone, the active androgen metabolite in the human prostate. In large,  double-blind, placebo-controlled phase III studies recruiting over 1600 patients, it was  shown that the administration of Finasteride, either 5 or 1 mg a day, reduced the size of  the prostate by a mean of 22%, following 6 months of therapy. Despite this reduction in  prostate size, urinary flow rate only improved by a mean of 1.7 ml per second and  symptom score improved only marginally, but statistically significantly different from  placebo. Long-term results in small series of patients have indicated a further  improvement beyond 1 year. After 3 years flow was improved by 60%. The future role  for Finasteride therapy is emerging, but it appears as if patients with mild to moderate  symptoms would be a group who could benefit the most. Whether or not Finasteride can  stop the long-term natural course of benign prostatic hyperplasia has still to be  demonstrated. 

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9.) Medical therapy for benign prostatic hyperplasia: A review of the literature. 

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Eur Urol 2000 Jul;38(1):2-19 

Clifford GM, Farmer RD 

Public Health and Primary Care Research Unit, European Institute of Health and Medical 

Sciences, University of Surrey, Surrey Research Park, UK. 

[Medline record in process] 

OBJECTIVE: To review the existing evidence regarding the efficacy and safety of  medical therapy for lower urinary tract symptoms (LUTS) indicative of benign prostatic  hyperplasia (BPH). To assess randomised controlled trials investigating the six  alpha-adrenergic receptor antagonists (alpha-blockers), prazosin, alfuzosin, indoramin,  terazosin, doxazosin, and tamsulosin, that benefit patients by relaxing prostatic smooth  muscle, and the anti-androgen, finasteride, that mediates its more long-term benefits by  reducing prostate size.

RESULTS:

This review suggests that both classes of drug offer  significant improvement in criteria used to evaluate symptomatic BPH and can be effective  whilst being acceptably safe. Furthermore, the therapeutic efficacy of all contemporary  alpha-blockers appear similar, both in terms of symptom relief and urodynamic  improvements. Randomised controlled trials have additionally demonstrated that  finasteride therapy can provide improvement in terms of quality of life indices, prostate  volume, and risks of progressing to acute urinary retention or prostatic surgery. While  alpha-blockers have a rapid onset of action, likely to produce a therapeutic result within  weeks, regardless of whether prostatic enlargement or bladder outlet obstruction is  present, finasteride appears to be effective for more long-term therapy for up to 4 years,  but only in alleviating symptoms when they are associated with a significantly large  prostate. Neither finasteride nor the alpha(1a)-receptor-selective blocker, tamsulosin, are  associated with the lowering of blood pressure and incidence of cardiovascular side  effects that are apparent with other less selective alpha-blocker therapies such as  dizziness and postural hypertension. They are, however, both associated with an  increased risk of sexual dysfunction, albeit less than those associated with surgical  intervention. Whereas tamsulosin is associated only with ejaculatory dysfunction,  finasteride is additionally linked to decreased libido and impotence.   

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10.) Pretreatment with finasteride decreases perioperative bleeding associated with 

transurethral resection of the prostate. 

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Urology 2000 May;55(5):684-9 

Hagerty JA, Ginsberg PC, Harmon JD, Harkaway RC 

Department of Surgery, Division of Urology, Albert Einstein Medical Center and 

Philadelphia College of Osteopathic Medicine, Philadelphia, Pennsylvania, USA. 

OBJECTIVES: The efficacy of finasteride in the treatment of gross hematuria associated  with benign prostatic hyperplasia is well established. We evaluated a regimen of  pretreatment with finasteride in decreasing perioperative bleeding associated with  transurethral resection of the prostate (TURP). METHODS: A prospective analysis  compared 25 patients pretreated with finasteride for 2 to 4 months before TURP with 50  patients without pretreatment. Patients in each group were further separated by the  amount of prostate tissue resected. Patients were then followed up for perioperative  bleeding, defined as a perioperative blood transfusion requirement or a return visit to the  emergency room with gross hematuria or clot retention.

RESULTS: None of the patients  with less than 30 g of prostate tissue resected experienced perioperative bleeding. In  patients with 30 g or more resected, several episodes of bleeding occurred. In the  patients pretreated with finasteride, 1 (8.3%) of 12 experienced perioperative bleeding; in  the control group, 7 (36.8%) of 19 had an episode of bleeding. CONCLUSIONS: In  patients with large prostate glands undergoing TURP, pretreatment with finasteride  appears useful in reducing perioperative bleeding. 

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11.) Urinary retention in patients with BPH treated with finasteride or placebo over 4 

years. Characterization of patients and ultimate outcomes.The PLESS Study Group. 

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Eur Urol 2000 May;37(5):528-36 

Roehrborn CG, Bruskewitz R, Nickel GC, Glickman S, Cox C, Anderson R, Kandzari 

S, Herlihy R, Kornitzer G, Brown BT, Holtgrewe HL, Taylor A, Wang D, Waldstreicher 

J 

The University of Texas Southwestern Medical Center, Dallas, TX 07525-9110, USA. 

claus.roehrborn@email.swmed.edu 

OBJECTIVES: Knowledge regarding the incidence and prevalence of acute urinary  retention and the ultimate outcome is very limited. The purpose of the present analysis  was to document the natural history and outcomes of acute urinary retention (AUR)  further specified as being either precipitated or spontaneous, and to evaluate the potential  benefit of finasteride therapy.

MATERIALS AND METHODS:

Three thousand and  forty men with moderate to severe symptoms of BPH and enlarged prostate glands by  digital rectal examination were enrolled into the 4-year placebo-controlled PLESS trial  and were evaluated for occurrences of AUR and BPH-related surgery. Men in the study  were seen every 4 months; discontinued patients were followed up 6 months after  discontinuation and again at the end of the 4-year trial. Complete 4-year data on  outcomes (occurrence of AUR or BPH-related surgery) was available for 92% of the  enrolled subjects in each treatment group. An endpoint committee, blinded to treatment  group and center, reviewed and categorized all study-related documentation relating to  retention and surgery.

RESULTS: Over the 4-year period, 99 of 1,503 placebo-treated  patients (6.6%) experienced one or more episodes of AUR in comparison with 42 or  1,513 finasteride-treated patients (2.8%; p<0. 001). Approximately half of the episodes  of retention were spontaneous and clearly BPH-related, while the other episodes were  precipitated by another factor (PAUR). After spontaneous AUR, subsequent surgery was  performed in 39 of 52 (75%) placebo-treated patients versus 8 of 20 (40%)  finasteride-treated patients (p = 0. 01). BPH-related surgery was less common in men  who had a prior episode of PAUR (26% in the placebo group and 14% in the finasteride  group). CONCLUSION: There is a continual risk of spontaneous and precipitated acute  urinary retention in men with moderate to severe lower urinary tract symptoms and an  enlarged prostate gland. Fewer patients who developed precipitated AUR than  spontaneous AUR go on to need subsequent BPH-related surgery. Significantly fewer  finasteride-than placebo-treated patients developed AUR, and among those men, fewer  ultimately needed BPH-related surgery. 

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12.) Dihydrotestosterone and the concept of 5alpha-reductase inhibition in human benign 

prostatic hyperplasia. 

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Eur Urol 2000 Apr;37(4):367-80 

Bartsch G, Rittmaster RS, Klocker H 

Department of Urology, University of Innsbruck, Austria. georg.bartsch@uibk.ac.at 

OBJECTIVE:The development of the human benign prostatic hyperplasia clearly requires  a combination of testicular androgens and aging. Although the role of androgens as the  causative factor for human benign prostatic hyperplasia is debated, they undoubtedly have  at least a permissive role. The principal prostatic androgen is dihydrotestosterone (DHT).  Although not elevated in human benign prostatic hyperplasia, DHT levels in the prostate  remain at a normal level with aging, despite a decrease in the plasma testosterone. 

 RESULTS:

 DHT is generated by reduction of testosterone. Two isoenzymes of  5alpha-reductase have been discovered. Type 1 is present in most tissues of the body  where 5alpha-reductase is expressed and is the dominant form in sebaceous glands.  Type2 5alpha-reductase is the dominant isoenzyme in genital tissues, including the  prostate. Finasteride is a 5alpha-reductase inhibitor that has been used for the treatment  of benign prostatic hyperplasia and male-pattern baldness. At doses used clinically, its  major effect is through suppression of type 2 5alpha-reductase, because it has a much  lower affinity for the type 1 isoenzyme. Finasteride suppresses DHT by about 70% in  serum and by as much as 85-90% in the prostate. The remaining DHT in the prostate is  likely to be the result of type 1 5alpha-reductase.

Suppression of both 5alpha-reductase  isoenzymes with GI198745 result in greater and more consistent suppression of serum  dihydrotestosterone than that observed with a selective inhibitor of type 2  5alpha-reductase. Physiological and clinical studies comparing dual 5alpha-reductase  inhibitors, such as GI198745, with selective type 2, such as finasteride, will be needed to  determine the clinical relevance of type 1 5alpha-reductase within the prostate. Two large  international multicenter, phase III trials have been published documenting the safety and  efficacy of finasteride in the treatment of human benign prostatic hyperplasia. Combining  these two studies, randomized, controlled data are available for 12 months.  Noncontrolled extension of these data from a subset of patients, who elected to continue  drug treatment for 3, 4 or 5 years, are also available. Long-term medical therapy with  finasteride can reduce clinically significant endpoints such as acute urinary retention or  surgery. According to the meta-analysis of six randomised clinical trial with finasteride,  finasteride is most effective in men with large prostates. A more effective dual inhibitor of  type 1 and 2 human 5alpha-reductase may lower circulating DHT to a greater extent than  finasteride and show advantages in the treatment of human benign prostatic hyperplasia  and other disease states that depend on DHT.

CONCLUSION:

Clinical evaluation of  potent dual 5alpha-reductase inhibitors may help define the relative roles of human type 1  and 2 5alpha-reductase in the pathophysiology of benign prostatic hyperplasia and other  androgen-dependent diseases. 

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13.) Chronic treatment with finasteride daily does not affect spermatogenesis or semen 

production in young men. 

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J Urol 1999 Oct;162(4):1295-300 Related Articles, Books, LinkOut 

Overstreet JW, Fuh VL, Gould J, Howards SS, Lieber MM, Hellstrom W, Shapiro S,  Carroll P, Corfman RS, Petrou S, Lewis R, Toth P, Shown T, Roy J, Jarow JP, Bonilla  J, Jacobsen CA, Wang DZ, Kaufman KD 

Department of Obstetrics and Gynecology, University of California, Davis, USA. 

PURPOSE:

Finasteride, an oral type 2, 5alpha-reductase inhibitor, is used in 1 mg. daily  doses for the treatment of male pattern hair loss. A dose of 5 mg. finasteride daily reduces  ejaculate volume by approximately 25%, and reduces prostate volume by approximately  20% and serum prostate specific antigen (PSA) by approximately 50% in men with  benign prostatic hyperplasia. To our knowledge no data exist on the effect of 1 mg.  finasteride daily on ejaculate volume or other semen parameters, or on the prostate in  young men. Therefore, we studied the potential effect and reversibility of effect of 1 mg.  finasteride daily on spermatogenesis, semen production, the prostate and serum PSA in  young men.

 MATERIALS AND METHODS:

In this double-blind, placebo controlled  multicenter study 181 men 19 to 41 years old were randomized to receive 1 mg.  finasteride or placebo for 48 weeks followed by a 60-week off-drug period. Of the 181  men 79 were included in a subset for the collection and analysis of sequential semen  samples. RESULTS: There were no significant effects of 1 mg. finasteride on sperm  concentration, total sperm per ejaculate, sperm motility or morphology. Ejaculate volume  in subjects on finasteride decreased 0.3 ml. (-11%) compared to a decrease of 0.2 ml.  (-8%) for placebo, with a median between treatment group difference of -0.03 ml. (1%,  90% confidence interval -10.4 to 13.1, p = 0.915). There were significant but small  decreases in prostate volume (-2.6%) and serum PSA (-0.2 ng./ml.) in the finasteride  group, which reversed on discontinuation of the drug.

CONCLUSIONS:

Treatment with  1 mg. finasteride daily for 48 weeks did not affect spermatogenesis or semen production  in young men. The effects of 1 mg. finasteride daily on prostate volume and serum PSA in  young men without benign prostatic hyperplasia were small and reversible on  discontinuation of the drug. 

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14.) Management of androgenetic alopecia. 

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J Eur Acad Dermatol Venereol 1999 May;12(3):205-14 Related Articles, Books, 

LinkOut 

Tosti A, Camacho-Martinez F, Dawber R 

Department of Dermatology, University of Bologna, Italy. tosti@almadns.unibo.it 

BACKGROUND:

 Androgenetic alopecia (AGA) is the most frequent cause of hair loss  affecting up to 50% of men and 40% of women by the age of 50.

 METHODS:

This  paper outlines the current status of diagnosis and offers guidelines for optimal management  of AGA in both men and women.

RESULTS:

The diagnosis of AGA can usually be  confirmed by medical history and physical examination alone. A trichogram can be useful  to assess the progression of the hair loss. A scalp biospy is diagnostic but usually not  required. In women with signs of hyperandrogenism, investigation for ovarian (polycystic  ovarian disease) or adrenal (late-onset congenital adrenal hyperplasia) disorders is  required. Mild to moderate AGA in men can be treated with oral finasteride or topical  minoxidil. Oral finasteride at the dosage of 1 mg/day produced clinical improvement in up  to 66% of patients treated for 2 years. The drug is effective for both frontal and vertex  hair thinning. Medical treatment with finasteride or minoxidil should be continued  indefinitely since interruption of therapy leads to hair loss with return to pretreatment  status. Mild to moderate AGA in women can be treated with oral antiandrogens  (cyproterone acetate, spironolactone) and/or topical minoxidil with good results in many  cases. Hair systems and surgery may be considered for selected cases of severe AGA  both in men and in women.

CONCLUSIONS:

 Patients with AGA should be informed  about the pathogenesis of the condition. If used correctly, available medical treatments  arrest progression of the disease and reverse miniaturization in most patients with mild to  moderate AGA. 

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15.) Finasteride in the treatment of men with frontal male pattern hair loss. 

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J Am Acad Dermatol 1999 Jun;40(6 Pt 1):930-7 Related Articles, Books, LinkOut 

Leyden J, Dunlap F, Miller B, Winters P, Lebwohl M, Hecker D, Kraus S, Baldwin H, 

Shalita A, Draelos Z, Markou M, Thiboutot D, Rapaport M, Kang S, Kelly T, Pariser D, 

Webster G, Hordinsky M, Rietschel R, Katz HI, Terranella L, Best S, Round E, 

Waldstreicher J 

University of Pennsylvania School of Medicine, Philadelphia, USA. 

BACKGROUND:

Finasteride, a specific inhibitor of type II 5alpha-reductase, decreases  serum and scalp dihydrotestosterone and has been shown to be effective in men with  vertex male pattern hair loss.

OBJECTIVE:

This study evaluated the efficacy of  finasteride 1 mg/day in men with frontal (anterior/mid) scalp hair thinning. METHODS:  This was a 1-year, double-blind, placebo-controlled study followed by a 1-year open  extension. Efficacy was assessed by hair counts (1 cm2 circular area), patient and  investigator assessments, and global photographic review.

RESULTS:

There was a  significant increase in hair count in the frontal scalp of finasteride-treated patients (P <  .001), as well as significant improvements in patient, investigator, and global photographic  assessments. Efficacy was maintained or improved throughout the second year of the  study. Finasteride was generally well tolerated. CONCLUSION: In men with hair loss in  the anterior/mid area of the scalp, finasteride 1 mg/day slowed hair loss and increased hair  growth. 

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16.) Androgenetic alopecia in men: the scale of the problem and prospects for treatment. 

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Int J Clin Pract 1999 Jan-Feb;53(1):50-3 Related Articles, Books, LinkOut 

Rushton DH 

School of Pharmacy and Biomedical Sciences, University of Portsmouth, Hants. 

While the precise incidence of androgenetic alopecia is unknown, it is universally  acknowledged to be the most common hair problem in men. Balding is generally  associated with ageing; consequently, the desire to prolong a youthful appearance  inevitably leads to demands for effective treatments. Further, changing attitudes in modern  society have resulted in people becoming concerned about their appearance and less  tolerant about conditions that might be alleviated by medical intervention. The importance  of hair loss upon quality of life has been underestimated by the medical profession.  Clinicians failing to accept hair loss as an important medical problem ignore the real  distress suffered by a significant proportion of those affected. New options for treatment  that selectively target the metabolic pathways involved in the balding process are showing  promise. The first generation of such drugs, Propecia, is now available in some countries  and other molecules are currently under development. 

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17.) [Androgenetic alopecia, hirsutism and hypertrichosis]. 

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Ther Umsch 1999 Apr;56(4):219-24 Related Articles, Books, LinkOut 

Trueb RM, Wyss M, Itin PH 

Dermatologische Klinik, Universitatsspital Zurich. 

Having too much hair on the face or the body and not enough on the scalp respectively, is  generally not a mirror of a life-threatening disease. However, the emotional impact of such  cosmetic problems may be remarkable in the individual case. Currently rational treatment  options are becoming increasingly available to correct such hair problems. This review  highlights the new therapeutic achievements in the treatment of both androgenetic alopecia  and hirsutism. Oral treatment of male patterned hair loss with finasteride in men is  emphasized, and the use of antiandrogens in women is discussed. In addition, the mode of  action and clinical results of topical minoxidil treatment find mention. The second part of  the review deals with hirsutism and hypertrichosis. The diagnostic steps and investigations  are briefly reviewed, and the advances in laser treatment of hirsutism and hypertrichosis  are presented. 

 

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Am Fam Physician 1999 Apr 15;59(8):2189-94, 2196 Related Articles, Books, 

LinkOut 

Scow DT, Nolte RS, Shaughnessy AF 

Harrisburg Family Practice Residency, PA 17105-8700, USA. 

Two drugs are available for the treatment of balding in men. Minoxidil, a topical product,  is available without a prescription in two strengths. Finasteride is a prescription drug taken  orally once daily. Both agents are modestly effective in maintaining (and sometimes  regrowing) hair that is lost as a result of androgenic alopecia. The vertex of the scalp is the  area that is most likely to respond to treatment, with little or no hair regrowth occurring on  the anterior scalp or at the hairline. Side effects of these medications are minimal, making  them suitable treatments for this benign but psychologically disruptive condition. 

=============================================================  19.) Understanding and managing common baldness. 

============================================================= 

Aust Fam Physician 1999 Mar;28(3):248-50, 252-3 

Tran D, Sinclair RD 

Department of Dermatology, St Vincent's Hospital, Melbourne. 

BACKGROUND:

Society places importance on physical attributes especially the  appearance of our hair. Common baldness or androgenetic alopecia is a normal  physiological process of hair loss in genetically predisposed individuals. Premature or  accelerated hair loss can engender considerable negative thoughts and anxiety associated  with feelings of diminished attractiveness. OBJECTIVE: To enable general practitioners to  recognise the various treatment options available, therefore offering patients reasonable  hope and informed choices.

DISCUSSION:

Common baldness can be prevented by  currently available mediums and regrowth may be achieved in a significant percentage of  cases. Correct use of these agents requires an understanding of the pathogenesis of  androgenetic alopecia, its natural history and the time course of response to treatment. 

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20.) Finasteride: a review of its use in male pattern hair loss. 

============================================================= 

Drugs 1999 Jan;57(1):111-26 Related Articles, Books, LinkOut 

McClellan KJ, Markham A 

Adis International Limited, Mairangi Bay, Auckland, New Zealand. demail@adis.co.nz 

The 5alpha-reductase inhibitor finasteride blocks the conversion of testosterone to  dihydrotestosterone (DHT), the androgen responsible for male pattern hair loss  (androgenetic alopecia) in genetically predisposed men. Results of phase III clinical  studies in 1879 men have shown that oral finasteride 1 mg/day promotes hair growth and  prevents further hair loss in a significant proportion of men with male pattern hair loss. 

 Evidence suggests that the improvement in hair count reported after 1 year is maintained  during 2 years' treatment. In men with vertex hair loss, global photographs showed  improvement in hair growth in 48% of finasteride recipients at 1 year and in 66% at 2  years compared with 7% of placebo recipients at each time point. Furthermore, hair  counts in these men showed that 83% of finasteride versus 28% of placebo recipients had  no further hair loss compared with baseline after 2 years. The clinical efficacy of oral  finasteride has not yet been compared with that of topical minoxidil, the only other drug  used clinically in patients with male pattern hair loss. Therapeutic dosages of finasteride  are generally well tolerated. In phase III studies, 7.7% of patients receiving finasteride 1  mg/day compared with 7.0% of those receiving placebo reported treatment-related  adverse events.

The overall incidence of sexual function disorders, comprising decreased  libido, ejaculation disorder and erectile dysfunction, was significantly greater in finasteride  than placebo recipients (3.8 vs 2.1%). All sexual adverse events were reversed on  discontinuation of therapy and many resolved in patients who continued therapy. No other  drug-related events were reported with an incidence > or =1% in patients receiving  finasteride. Most events were of mild to moderate severity. Oral finasteride is  contraindicated in pregnant women because of the risk of hypospadias in male fetuses. 

 CONCLUSIONS:

Oral finasteride promotes scalp hair growth and prevents further hair  loss in a significant proportion of men with male pattern hair loss. With its generally good  tolerability profile, finasteride is a new approach to the management of this condition, for  which treatment options are few. Its role relative to topical minoxidil has yet to be  determined. 

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21.) Finasteride in the treatment of men with androgenetic alopecia. Finasteride Male 

Pattern Hair Loss Study Group. 

============================================================= 

J Am Acad Dermatol 1998 Oct;39(4 Pt 1):578-89 

Kaufman KD, Olsen EA, Whiting D, Savin R, DeVillez R, Bergfeld W, Price VH, Van 

Neste D, Roberts JL, Hordinsky M, Shapiro J, Binkowitz B, Gormley GJ 

Department of Clinical Research, Merck Research Laboratories, Rahway, NJ 07065, 

USA. /font>

BACKGROUND:

 Androgenetic alopecia (male pattern hair loss) is caused by  androgen-dependent miniaturization of scalp hair follicles, with scalp dihydrotestosterone  (DHT) implicated as a contributing cause. Finasteride, an inhibitor of type II  5alpha-reductase, decreases serum and scalp DHT by inhibiting conversion of  testosterone to DHT.

OBJECTIVE:

Our purpose was to determine whether finasteride  treatment leads to clinical improvement in men with male pattern hair loss.

METHODS:

In  two 1-year trials, 1553 men (18 to 41 years of age) with male pattern hair loss received  oral finasteride 1 mg/d or placebo, and 1215 men continued in blinded extension studies  for a second year. Efficacy was evaluated by scalp hair counts, patient and investigator  assessments, and review of photographs by an expert panel. RESULTS: Finasteride  treatment improved scalp hair by all evaluation techniques at 1 and 2 years (P < .001 vs  placebo, all comparisons). Clinically significant increases in hair count (baseline = 876  hairs), measured in a 1-inch diameter circular area (5.1 cm2) of balding vertex scalp,  were observed with finasteride treatment (107 and 138 hairs vs placebo at 1 and 2 years,  respectively; P < .001). Treatment with placebo resulted in progressive hair loss. Patients'  self-assessment demonstrated that finasteride treatment slowed hair loss, increased hair  growth, and improved appearance of hair. These improvements were corroborated by  investigator assessments and assessments of photographs. Adverse effects were minimal. 

CONCLUSION:

 In men with male pattern hair loss, finasteride 1 mg/d slowed the  progression of hair loss and increased hair growth in clinical trials over 2 years.   

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22.) Genetic analysis of male pattern baldness and the 5alpha-reductase genes. 

============================================================= 

J Invest Dermatol 1998 Jun;110(6):849-53 Related Articles, Books, LinkOut 

Ellis JA, Stebbing M, Harrap SB 

Department of Physiology, The University of Melbourne, Parkville, Victoria, Australia. 

Genetic predisposition and androgen dependence are important characteristics of the  common patterned loss of scalp hair known as male pattern baldness. The involvement of  the 5alpha-reductase enzyme in male pattern baldness has been postulated due to its role  in the metabolism of testosterone to dihydrotestosterone.

There are two known isozymes  of 5alpha-reductase. Type I has been predominantly localized to the skin and scalp. Type  II, also present on the scalp, is the target of finasteride, a promising treatment for male  pattern baldness. We conducted genetic association studies of the 5alpha-reductase  enzyme genes (SRD5A1 on chromosome 5 and SRD5A2 on chromosome 2) using  dimorphic intragenic restriction fragment length polymorphisms. >From a population  survey of 828 healthy families comprising 3000 individuals, we identified 58 young bald  men (aged 18-30 y) and 114 older nonbald men (aged 50-70 y) for a case control  comparison.

No significant differences were found between cases and controls in allele,  genotype, or haplotype frequencies for restriction fragment length polymorphisms of either  gene. These findings suggest that the genes encoding the two 5alpha-reductase  isoenzymes are not associated with male pattern baldness. Finally, no clear inheritance  pattern of male pattern baldness was observed. The relatively strong concordance for  baldness between fathers and sons in this study was not consistent with a simple  Mendelian autosomal dominant inheritance. A polygenic etiology should be considered. 

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23.) Effect of finasteride on human testicular steroidogenesis. 

============================================================= 

J Androl 1996 Sep-Oct;17(5):516-21 Related Articles, Books 

Castro-Magana M, Angulo M, Fuentes B, Canas A, Sarrantonio M, Arguello R, Vitollo 

P 

Department of Pediatrics, Winthrop-University Hospital, Mineola, New York 11501, 

USA. 

We studied the testicular function and some androgen-mediated events in 22 males  (16-30 years of age) with male pattern baldness that was treated with finasteride (10 mg  once daily) for 2 years. Patients were evaluated every 3 months. Prostatic volume was  determined in six subjects by endorectal ultrasound scans.

Serum gonadotropin,  prostate-specific antigen (PSA), and sex hormone levels were determined basally and  periodically during the treatment period. Fourteen subjects underwent gonadal stimulation  with human chorionic gonadotropin (hCG), and the gonadotropin response to  gonadotropin releasing hormone (GnRH) was determined in eight subjects, prior to and  after 2 years of therapy.

Finasteride treatment resulted in an improvement in the male  pattern baldness and prostatic shrinkage that was associated with an increase in serum  testosterone levels (17.2 +/- 2.5 vs. 26.3 +/- 1.7 nmol/L) and a decrease in  dihydrotestosterone (DHT) levels (1.45 +/- 0.41 vs. 0.38 +/- 0.10 nmol/L), causing a  marked increase in that testosterone/DHT ratio. A significant increase in the serum levels  of androstenedione (3.67 +/- 0.49 vs. 7.05 +/- 0.70 nmol/L) and estradiol (132 +/- 44  vs. 187 +/- 26 pmol/L) was also noted, whereas androstanediol glucoronide (33.3 +/-  6.4 vs. 10.7 +/- 4.5 pmol) and PSA (1.6 +/- 0.6 vs. 0.4 +/- 0.1 ng/ml) were significantly  decreased. No changes in basal or stimulated levels of gonadotropin were observed. 

There was a significant increase in the testosterone response to hCG during finasteride  therapy (delta: 16.7 vs. 35.5 nmol/L) that could be explained, at least in part, by the  reduction of testosterone metabolism resulting from the blockage induced by finasteride.  The decrease in the androstenedione to testosterone and estrone to estradiol ratios  observed after hCG treatment, however, strongly suggests increased activity of the  17-ketosteroid reductase enzyme and an improvement of the testicular capacity for  testosterone production. 

=============================================================  BR>224.) [Finasteride: a new drug for the treatment of male hirsutism and  androgenetic 

alopecia]? 

============================================================= 

Clin Ter 1996 Jun;147(6):305-15 Related Articles, Books, LinkOut 

[Article in Italian] 

Spinucci G, Pasquali R 

Dipartimento di Medicina interna e Gastroenterologia, Policlinico S. Orsola-Malpighi, 

Bologna. 

Finasteride is a drug which inhibits the transformation of testosterone into its active  metabolite, dihydrotestosterone, in the target organs, i.e. the skin, the scalp, the liver and  the prostate. In the pathogenic mechanism of hirsutism and androgenetic alopecia, and  important role is presumably played by alterations of the mechanisms which transform  testosterone into dihydrotestosterone. In some conditions an increase in  dihydrotestosterone has been demonstrated, due to increased activity of the enzyme 5  alpha-reductase.

The effect of finasteride develops above all at the level of type II 5  alpha-reductase. Recent studies have evaluated the effect of finasteride in patients of both  sexes with hirsutism and androgenetic alopecia. In women with various forms of  hyperandrogenism, the use of the drug at the doses commonly used for the treatment of  benign prostatic hyperplasia seems to have induced a significant reduction in the degree of  hirsutism.

Furthermore, both in animals and men with alopecia, the drug seems to have led  to an increase in the number and an improvement in the shape of the follicles in the anagen  phase, and a simultaneous decrease of dehydrotestosterone at the level of the scalp. This  study represents a review of the main results obtained over the last two years and reports  the prospects which the use of finasteride may have in this context. 

============================================================= 

25.) The 5 alpha-reductase system and its inhibitors. Recent development and its 

perspective in treating androgen-dependent skin disorders. 

============================================================= 

Dermatology 1996;193(3):177-84 Related Articles, Books, LinkOut 

Chen W, Zouboulis CC, Orfanos CE 

Department of Dermatology, University Medical Center Benjamin Franklin, Free 

University of Berlin, Germany. 

5 alpha-Reductase, the enzyme system that metabolizes testosterone into  dihydrotestosterone, occurs in two isoforms. The type 1 isozyme is composed of 259  amino acids, has an optimal pH of 6-9 and represents the 'cutaneous type'; it is located  mainly in sebocytes but also in epidermal and follicular keratinocytes, dermal papilla cells  and sweat glands as well as in fibroblasts from genital and non-genital skin. The type 2  isozyme is composed of 254 amino acids, has an optimal pH of about 5.5 and is located  mainly in the epididymis, seminal vesicles, prostate and fetal genital skin as well as in the  inner root sheath of the hair follicle and in fibroblasts from normal adult genital skin. The  genes encoding type 1 and type 2 isozymes are found in chromosomes 5p and 2p,  respectively, and each consists of 5 exons and 4 introns.

During the last decade, several  steroid analogues and non-steroid agents have been developed to interfere with 5  alpha-reductase activity. Finasteride, which has a higher affinity for the type 2 isozyme, is  the first 5 alpha-reductase antagonist clinically introduced for treatment of benign prostate  hyperplasia. The clinical evaluation of finasteride or other 5 alpha-reductase inhibitors in  the field of dermatology has been very limited; in particular, those that selectively bind to  type 1 isozyme (e.g. MK-386, LY191704) may be regarded as candidates for treatment  of androgen-dependent skin disorders such as seborrhoea, acne, hirsutism and/or  androgenetic alopecia. 

============================================================= 

26.) Finasteride: a clinical review. 

============================================================= 

Biomed Pharmacother 1995;49(7-8):319-24 Related Articles, Books 

Gormley GJ 

Merck Research Laboratories, Rahway, NJ 07065-0914, USA. 

Finasteride is the first of a new class of 5 alpha-reductase inhibitors which allows selective  androgen deprivation affecting dihydrotestosterone (DHT) levels in target organs such as  the prostate and scalp hair without effecting circulating levels of testosterone thus  preserving the desired androgen mediated effects on muscle strength, bone density and  sexual function. Finasteride has been demonstrated to produce significant effects in men  with an enlarged prostate gland. The long-term data now emerging suggests that  progression of benign prostatic hyperplasia (BPH) may be arrested providing additional  long term benefits. Experimental uses in prostate cancer prevention and male pattern  baldness offer new and exciting possibilities for this class of compounds.   

============================================================= 

27.) The effect of finasteride, a 5 alpha-reductase inhibitor, on scalp skin testosterone and 

dihydrotestosterone concentrations in patients with male pattern baldness. 

============================================================= 

J Clin Endocrinol Metab 1994 Sep;79(3):703-6 Related Articles, Books, LinkOut 

Dallob AL, Sadick NS, Unger W, Lipert S, Geissler LA, Gregoire SL, Nguyen HH, 

Moore EC, Tanaka WK 

Merck Research Laboratories, Rahway, New Jersey 07065. 

The effects of the 5 alpha-reductase inhibitor, finasteride, on scalp skin testosterone (T)  and dihydrotestosterone (DHT) levels were studied in patients with male pattern baldness.  In a double blind study, male patients undergoing hair transplantation were treated with  oral finasteride (5 mg/day) or placebo for 28 days. Scalp skin biopsies were obtained  before and after treatment for measurement of T and DHT by high pressure liquid  chromatography-RIA. In 10 male subjects studied at baseline, mean (+/- SEM) DHT  levels were significantly higher in bald (7.37 +/- 1.24 pmol/g) compared to hair-containing  (4.20 +/- 0.65 pmol/g) scalp, whereas there was no difference in mean T levels at  baseline. In bald scalp from 8 patients treated with finasteride, the mean DHT  concentration decreased from 6.40 +/- 1.07 pmol/g at baseline to 3.62 +/- 0.38 pmol/g  on day 28. Scalp T levels increased in 6 of 8 subjects treated with finasteride.

Finasteride  decreased the mean serum DHT concentration from 1.36 +/- 0.18 nmol/L (n = 8) at  baseline to 0.46 +/- 0.10 nmol/L on day 28 and had no effect on serum T. There were no  significant changes in scalp or serum T or DHT in placebo-treated patients. In this study,  male subjects treated with 5 mg/day finasteride for 4 weeks had significantly decreased  concentrations of DHT in bald scalp, resulting in a mean level similar to the baseline levels  found in hair-containing scalp. 

============================================================= 

28.) Finasteride: the first 5 alpha-reductase inhibitor. 

============================================================= 

Pharmacotherapy 1993 Jul-Aug;13(4):309-25; discussion 325-9 Related Articles, 

Books 

Sudduth SL, Koronkowski MJ 

Program on Aging, School of Pharmacy, University of North Carolina, Chapel Hill 

27599-7360. 

Finasteride is a synthetic 4-azasteroid that is a specific competitive inhibitor of 5  alpha-reductase, an intracellular enzyme that converts testosterone to dihydrotestosterone  (DHT). It has no binding affinity for androgen receptor sites and itself possesses no  androgenic, antiandrogenic, or other steroid hormone-related properties. It is well  absorbed after oral administration, with absolute bioavailability in humans of 63% (range  34-108%). The mean time to maximum concentration is 1-2 hours, and it is  approximately 90% plasma protein bound. The elimination half-life averages 6-8 hours. 

The agent is metabolized to a series of five metabolites, of which two are active and  possess less than 20% of the 5 alpha-reductase activity of finasteride. Little is known  about potential drug interactions, although they appear to be minimal and not clinically  relevant. The drug is indicated for the treatment of symptomatic benign prostatic  hyperplasia. Its efficacy in regression of prostate gland enlargement is rapid and  predictable, although correlation with subsequent improvement in urinary flow and  symptoms is highly variable.

Dosages of 0.5-100 mg/day regress prostate enlargement;  the recommended dosage is 5 mg once/day. Finasteride may hold promise for other  DHT-mediated disorders such as acne, facial hirsutism, frontal lobe alopecia, and  prostate cancer, but its use in these conditions remains investigational.

The frequency of  adverse drug events is low, with the most common side effects being impotence,  decreased libido, and decreased volume of ejaculate. No reports of intentional overdose  have been reported, and dosages of up to 80 mg/day for 3 months have been taken  without adverse effect. 

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29.) Cytologic atypia in a 53-year-old man with finasteride-induced gynecomastia. 

============================================================= 

Arch Pathol Lab Med 2000 Apr;124(4):625-7 Related Articles, Books, LinkOut 

Zimmerman RL, Fogt F, Cronin D, Lynch R 

Departments of Pathology & Laboratory Medicine, Presbyterian Medical Center, 

University of Pennsylvania Health System, Philadelphia, PA 19104, USA. 

Finasteride has been associated with the development of gynecomastia. Although  cytoplasmic vacuolization has been noted in prostatic epithelium in men taking this drug,  we found no documentation of the cytologic changes in finasteride-associated  gynecomastia. We present the case of a 53-year-old man who developed unilateral  gynecomastia following finasteride therapy for alopecia. A fine-needle aspiration biopsy of  the mass was diagnosed as adenocarcinoma on the basis of nuclear atypia and particularly  because of cytoplasmic vacuolization.

Subsequent excisional biopsy revealed benign  gynecomastia with no evidence of malignant change. The ductal epithelium did exhibit  cytoplasmic vacuolization similar to that described in the prostate following finasteride  therapy. We believe this is the first reported case documenting the cytologic changes seen  in gynecomastia secondary to finasteride therapy. Cytoplasmic vacuolization in this setting  should not be considered evidence of malignancy in men with gynecomastia. As with  gynecomastia in general, extreme caution should be used before rendering a cytologic  diagnosis of malignancy. 

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30.) Reversible painful gynaecomastia induced by low dose finasteride (1 mg/day). 

============================================================= 

Australas J Dermatol 2000 Feb;41(1):55 Related Articles, Books, LinkOut 

Wade MS, Sinclair RD 

Publication Types: 

Letter 

============================================================= /font>

============================================================== 

31.) Measuring reversal of hair miniaturization in androgenetic alopecia by follicular counts 

in horizontal sections of serial scalp biopsies: results of finasteride 1 mg treatment of men 

and postmenopausal women. 

============================================================= 

J Investig Dermatol Symp Proc 1999 Dec;4(3):282-4 Related Articles, Books, LinkOut 

Whiting DA, Waldstreicher J, Sanchez M, Kaufman KD 

Baylor Hair Research and Treatment Center, Baylor University Medical Center, Dallas, 

Texas 75246, USA. 

Hair regrowth was evaluated by histologic analysis in men and women treated for  androgenetic alopecia, by counting follicles in horizontal sections of scalp biopsies. Serial  4mm punch biopsies were taken at baseline and after 12mo of treatment from the  transitional area of hair thinning between normal hair and vertex balding in men, and in an  area of frontal/parietal thinning in women. Horizontal sections of reticular and papillary  dermis were read by one observer, blinded to patient, treatment, and time. All terminal  hair bulbs, terminal anagen and telogen hairs, and vellus and vellus-like miniaturized hairs  were counted.

Twenty-six men aged 18-41y, comprising 14 on finasteride 1 mg daily and  12 on placebo, and 94 postmenopausal women, aged 41-60y, comprising 44 on  finasteride 1 mg daily and 50 on placebo, were evaluated. In the male study, the terminal  hairs increased from a mean baseline count of 15.5-20.9 after 12mo of finasteride, versus  17.3-18.3 in the placebo patients.

The miniaturized hairs decreased from 26.7 to 23.6  with finasteride versus 21.3-20.3 with placebo. The terminal-to-vellus ratio increased  more in the finasteride than in the placebo patients, suggesting some reversal of the  miniaturization process with finasteride. In the female study, no significant differences in  follicular counts were found between the finasteride and placebo groups after 12mo of  treatment. Follicular counts in horizontal sections provide an informative adjunct to  noninvasive measures used in hair growth studies. Finasteride appears to be capable of  reversing hair miniaturization in androgenetic alopecia in young to middle-aged men, but  not in postmenopausal women. 

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32.) Improvement in androgenetic alopecia in 53-76-year-old men using oral finasteride. 

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Int J Dermatol 1999 Dec;38(12):928-30 Related Articles, Books, LinkOut 

Brenner S, Matz H 

Department of Dermatology, Tel Aviv Sourasky Medical Center, Tel Aviv, Israel. 

Twenty-eight men with AGA, aged 53-76 years (mean, 65 years), were selected to  participate in this trial from a double blind, placebo controlled, multicenter study of  subjects with moderate symptoms of BPH. Patients received either finasteride 5 mg or  placebo daily for 24 months. Hair counts were performed at entry to the study and at 6,  12, 18, and 24 months. Hair counts were made directly on the scalp in a circular target  area 1 in in diameter, located in the center of a template. The template was applied in  such a way that its counting window fell on the most balding scalp area, which remained  the same for each patient.11 At each hair counting session, patients were asked about  side-effects and questioned about their sex life. Time trend and differences between  groups were examined using a one-way (treatment) MANOVA with repeated measures  (baseline, 6, 12, 18, and 24 months). Additional two-tailed t-tests were performed to  compare the two groups at each point of time. P < 0.05 was considered to be significant. 

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33.) New topical antiandrogenic formulations can stimulate hair growth in human bald 

scalp grafted onto mice. 

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Int J Pharm 2000 Jan 20;194(1):125-34 Related Articles, Books, LinkOut 

Sintov A, Serafimovich S, Gilhar A 

Ben-Gurion University of the Negev, The Institutes for Applied Research, PO Box 653, 

Beer-Sheva, Israel. asintov@bgumail.bgu.ac.il 

The purpose of this study was to test the ability of topical formulations of finasteride and  flutamide to re-enlarge hair follicles in male-pattern baldness. This was evaluated by an  experimental model of human scalp skin graft transplanted onto SCID mice.

 A  comparison was made between formulations containing finasteride and flutamide, and a  vehicle formulation in terms of the mean hairs per graft, length, diameter of the shafts, and  structures of the growth stages of the hair. Flutamide and finasteride had a significantly  higher effect (P<0.05) than the placebo in all the tested parameters, but flutamide  demonstrated more hair per graft and longer hair shafts than finasteride (P<0.05). The  number of hairs per graft for flutamide and finasteride groups were 1.22+/-0. 47 and  0.88+/-0.95 hairs/0.5 mm2 graft, respectively, versus 0. 35+/-0.6 hairs/graft for  vehicle-treated graft. Similarly, hair lengths for flutamide and finasteride were 5.82+/-0.50  and 4.50+/-0. 32 mm, respectively, versus 2.83+/-0.18 mm for the vehicle-treated grafts. 

An in vitro diffusion study of flutamide gel using hairless mouse skin demonstrated the  beneficial effect of the vehicle composition in comparison with a hydroalcoholic solution  or a gel containing no penetration enhancer. It is therefore suggested that this topical  composition containing flutamide or finasteride may effectively result in regression of  male-pattern baldness. 

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34.) Current management of androgenetic alopecia in men. 

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Eur J Dermatol 1999 Dec;9(8):606-9 Related Articles, Books, LinkOut 

Wolff H, Kunte C 

Klinik fur Dermatologie und Allergologie, Ludwig-Maximilians-Universitat,  Frauenlobstrasse 9-11, D-80337, Munchen, Germany. hans.wolff@lrz.uni-muenchen.de 

Androgenetic alopecia (AGA) is a common dermatological condition affecting both men  and women. Until recently there has been little interest in AGA as a clinical condition,  largely due to the lack of any genuinely effective treatment for it. A number of "remedies"  exist, such as vitamin supplements, which are not generally harmful but which have no  proven efficacy in promoting hair growth or preventing further hair loss. Hair systems and  surgery provide camouflage for the symptoms but do not effect a cure. By far the most  promising approaches to the treatment of AGA are drug therapies, such as minoxidil and  finasteride. Finasteride, an inhibitor of the type II 5alpha-reductase that converts  testosterone to dihydrotestosterone, has been shown to prevent further hair loss, and  promotes new hair growth in the majority of the men taking part in clinical trials. Tailored  drug approaches like this offer the greatest hope for the successful future treatment of  alopecia. 

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35.) Immunohistochemical localization of types 1 and 2 5alpha-reductase in human scalp. 

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Br J Dermatol 1999 Sep;141(3):481-91 Related Articles, Books, LinkOut 

Bayne EK, Flanagan J, Einstein M, Ayala J, Chang B, Azzolina B, Whiting DA, Mumford 

RA, Thiboutot D, Singer II, Harris G 

Merck Research Laboratories, PO Box 2000, Rahway, NJ 07065, USA. 

ellen_bayne@merck.com 

The predominant form of 5alpha-reductase (5aR) in human scalp is 5aR1. None the less,  clinical studies have shown that finasteride, a selective inhibitor of 5aR2, decreases scalp  dihydrotestosterone and promotes hair growth in men with androgenetic alopecia. 

Immunolocalization studies were thus carried out to examine 5aR isozyme distribution  within scalp and, in particular, to determine whether 5aR2 might be associated with hair  follicles. 5aR2 was localized using both a rabbit polyclonal and a mouse monoclonal  antibody. 5aR1 was detected with a mouse monoclonal antibody.

The specificity of these  reagents was demonstrated both by immunofluorescence and Western blot analyses of  COS cells overexpressing human 5aR1 or 5aR2. When cryosections of scalp from men  with androgenetic alopecia were stained with antibody against 5aR2, using  immunoperoxidase avidin-biotin complex methodology, immunostaining was observed in  the inner layer of the outer root sheath and, in more proximal regions of the follicle, in the  inner root sheath. Staining was also prominent in the infundibular region of the follicle, with  less intense staining extending throughout the granular layer of the epidermis.

Some  staining was also seen in sebaceous ducts. Similar results were obtained with both the  polyclonal and monoclonal 5aR2 antibodies. In contrast, in scalp cryosections stained  with antibody to 5aR1, no immunostaining was observed within hair follicles. Intense  staining for the type 1 isozyme was, however, detected within sebaceous glands. Our  immunolocalization data suggest that the results seen in clinical trials of men with male  pattern hair loss treated with finasteride may be due, at least in part, to local inhibition of  5aR2 within the hair follicle. 

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36.) The psychosocial consequences of androgenetic alopecia: a review of the research 

literature. 

============================================================= 

Br J Dermatol 1999 Sep;141(3):398-405 Related Articles, Books, LinkOut 

Cash TF 

Department of Psychology, Old Dominion University, Norfolk, VA 23529-0267, USA. 

Androgenetic alopecia is a common dermatological condition, with potentially adverse  psychosocial sequelae. The present review critically examines scientific evidence  concerning the effects of androgenetic hair loss on social processes and psychological  functioning, as well as the psychosocial outcomes of medical treatments. Research  confirms a negative but modest effect of visible hair loss on social perceptions.

More  importantly, androgenetic alopecia is typically experienced as a moderately stressful  condition that diminishes body image satisfaction. Deleterious effects on self-esteem and  certain facets of psychological adjustment are more apparent among women than men  and among treatment-seeking patients. Various 'risk factors' vis-a-vis the psychological  adversity of androgenetic alopecia are identified. Medical treatments, i.e. minoxidil and  finasteride, appear to have some psychological efficacy.

A conceptual model is delineated  to explain the psychological effects of hair loss and its treatment. Directions for needed  research are discussed. Strategies are presented for the clinical management of  psychological issues among these patients. 

 

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37.) Clinical dose ranging studies with finasteride, a type 2 5alpha-reductase inhibitor, in 

men with male pattern hair loss. 

============================================================= 

J Am Acad Dermatol 1999 Oct;41(4):555-63 Related Articles, Books, LinkOut 

Roberts JL, Fiedler V, Imperato-McGinley J, Whiting D, Olsen E, Shupack J, Stough D,  DeVillez R, Rietschel R, Savin R, Bergfeld W, Swinehart J, Funicella T, Hordinsky M,  Lowe N, Katz I, Lucky A, Drake L, Price VH, Weiss D, Whitmore E, Millikan L, Muller  S, Gencheff C, et al 

Northwest Cutaneous Research Specialists, Portland, Oregan, USA. 

BACKGROUND:

Androgenetic alopecia is a common condition of adult men.  Finasteride, a type 2 5alpha-reductase inhibitor, decreases the formation of  dihydrotestosterone from testosterone. OBJECTIVE: Two separate clinical studies were  conducted to establish the optimal dose of finasteride in men with this condition. 

METHODS:

Men from 18 to 36 years of age with moderate vertex male pattern hair loss  received finasteride 5, 1, 0.2, or 0.01 mg/day or placebo based on random assignment.  Efficacy was determined by scalp hair counts, patient self-assessment, investigator  assessment, and assessment of clinical photographs. Safety was assessed by clinical and  laboratory measurements and by analysis of adverse experiences.

RESULTS:

Efficacy  was demonstrated for all end points for finasteride at doses of 0.2 mg/day or higher, with  1 and 5 mg demonstrating similar efficacy that was superior to lower doses. Efficacy of  the 0.01 mg dose was similar to placebo. No significant safety issues were identified in the  trials.

CONCLUSION:

Finasteride 1 mg/day is the optimal dose for the treatment of men  with male pattern hair loss and was subsequently identified for further clinical  development. 

=============================================================  BR>38.) The effects of finasteride on scalp skin and serum androgen levels in men with 

androgenetic alopecia. 

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J Am Acad Dermatol 1999 Oct;41(4):550-4 Related Articles, Books, LinkOut 

Drake L, Hordinsky M, Fiedler V, Swinehart J, Unger WP, Cotterill PC, Thiboutot DM, 

Lowe N, Jacobson C, Whiting D, Stieglitz S, Kraus SJ, Griffin EI, Weiss D, Carrington 

P, Gencheff C, Cole GW, Pariser DM, Epstein ES, Tanaka W, Dallob A, Vandormael 

K, Geissler L, Waldstreicher J 

University of Oklahoma Health Sciences, Oklahoma City, USA. 

BACKGROUND:

Data suggest that androgenetic alopecia is a process dependent on  dihydrotestosterone (DHT) and type 2 5alpha-reductase. Finasteride is a type 2  5alpha-reductase inhibitor that has been shown to slow further hair loss and improve hair  growth in men with androgenetic alopecia.

OBJECTIVE:

We attempted to determine the  effect of finasteride on scalp skin and serum androgens.

METHODS:

Men with  androgenetic alopecia (N = 249) underwent scalp biopsies before and after receiving  0.01, 0.05, 0.2, 1, or 5 mg daily of finasteride or placebo for 42 days. RESULTS: Scalp  skin DHT levels declined significantly by 13.0% with placebo and by 14.9%, 61.6%, 56.  5%, 64.1%, and 69.4% with 0.01, 0.05, 0.2, 1, and 5 mg doses of finasteride,  respectively. Serum DHT levels declined significantly (P <.001) by 49.5%, 68.6%,  71.4%, and 72.2% in the 0.05, 0.2, 1, and 5 mg finasteride treatment groups,  respectively.

CONCLUSION:

 In this study, doses of finasteride as low as 0.2 mg per  day maximally decreased both scalp skin and serum DHT levels. These data support the  rationale used to conduct clinical trials in men with male pattern hair loss at doses of  finasteride between 0.2 and 5 mg. 

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DATA-MÉDICOS/DERMAGIC-EXPRESS No 2-(95)  25/08/2000 DR. JOSÉ LAPENTA R. 

UPDATED 18 JULY 2025

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Produced by Dr. José Lapenta R. Dermatologist

Venezuela 1.998-2.025

Producido por Dr. José Lapenta R. Dermatólogo Venezuela 1.998-2.025

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